Using Technology to Improve Eating Disorders Treatment

NCT ID: NCT02076464

Last Updated: 2019-11-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 690 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-12
• Study Completion Date: 2018-11-27

Brief Summary

The purpose is to evaluate a technologically-enhanced, guided self-help program to reduce eating disorder outcomes in college-age women.

Detailed Description

Colleges are faced with an elevated prevalence of eating disorders, yet less than 20% of students report receiving treatment. Inadequacies in mental health care delivery result in prolonged illness, disease progression, poorer prognosis, and greater likelihood of relapse, highlighting the need for improved modalities for screening and intervention. Over the past 20 years, we have developed a comprehensive, online platform through which we identify and offer tailored evidence-based interventions to individuals across the eating disorder risk and diagnostic spectrum, using minimal person-based resources. The newest intervention in our suite of programs, Student Bodies-Eating Disorders (SB-ED), has not yet been tested in a large-scale trial or via platform delivery. The aim of this study is to conduct the first national deployment of our comprehensive platform and demonstrate that our transdiagnostic guided self-help program, SB-ED, yields measurable and significant improvements in access, costs, and outcomes for eating disorder treatment over referral to usual care (i.e., treatment per protocol at students' corresponding college's mental health services center).

Twenty-eight colleges will be randomly assigned to receive either SB-ED or referral to usual care. We will enroll at least 650 students from these campuses who screen positive for a DSM-5 clinical or subclinical eating disorder (excluding anorexia nervosa, which warrants more intensive medical monitoring). Outcomes will be measured at 6-months, 1-year, and 2-years following the completion of the online screen.

Conditions

Eating Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

StudentBodies - Eating Disorders

Participants will participate in the StudentBodies - Eating Disorders program

Group Type: EXPERIMENTAL

StudentBodies - Eating Disorders

Intervention Type: BEHAVIORAL

The intervention is a structured, cognitive-behavioral guided self-help program, derived from manual-based cognitive-behavioral therapy. The intervention targets the core eating disorder pathology (e.g., extreme dietary restraint, overvaluation of shape and weight, binge eating, compensatory behaviors), focusing on helping users develop regular eating patterns, self-control strategies, problem-solving skills, and relapse prevention tools for maintenance of behavior change. The program includes daily symptom checklists, journal exercises and activities, and an asynchronous moderated online discussion group.

Usual Care

Participants will be referred to treatment per protocol at students' corresponding college's mental health services center

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

StudentBodies - Eating Disorders

The intervention is a structured, cognitive-behavioral guided self-help program, derived from manual-based cognitive-behavioral therapy. The intervention targets the core eating disorder pathology (e.g., extreme dietary restraint, overvaluation of shape and weight, binge eating, compensatory behaviors), focusing on helping users develop regular eating patterns, self-control strategies, problem-solving skills, and relapse prevention tools for maintenance of behavior change. The program includes daily symptom checklists, journal exercises and activities, and an asynchronous moderated online discussion group.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Student at a participating college or university ages 18-30
• Screen positive for DSM-5 bulimia nervosa, binge eating disorder, or a subclinical eating disorder

Exclusion Criteria

• Screen positive for DSM-5 anorexia nervosa
• No access to the internet
• Acutely suicidal

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: collaborator

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Denise Wilfley

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Denise E. Wilfley, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

C. Barr Taylor, M.D.

Role: PRINCIPAL_INVESTIGATOR

Stanford University

References

Graham AK, Fitzsimmons-Craft EE, Sadeh-Sharvit S, Balantekin KN, Eichen DM, Firebaugh ML, Goel NJ, Monterubio GE, Karam AM, Flatt RE, Jo B, Jacobi C, Wilfley DE, Taylor CB, Trockel M. Moderators and mediators of a digital cognitive behavior therapy-guided self-help intervention for eating disorders: Informing future design efforts. J Consult Clin Psychol. 2023 May;91(5):280-284. doi: 10.1037/ccp0000786. Epub 2023 Jan 12.

Reference Type: DERIVED

PMID: 36634022 (View on PubMed)

Fitzsimmons-Craft EE, Taylor CB, Graham AK, Sadeh-Sharvit S, Balantekin KN, Eichen DM, Monterubio GE, Goel NJ, Flatt RE, Karam AM, Firebaugh ML, Jacobi C, Jo B, Trockel MT, Wilfley DE. Effectiveness of a Digital Cognitive Behavior Therapy-Guided Self-Help Intervention for Eating Disorders in College Women: A Cluster Randomized Clinical Trial. JAMA Netw Open. 2020 Aug 3;3(8):e2015633. doi: 10.1001/jamanetworkopen.2020.15633.

Reference Type: DERIVED

PMID: 32865576 (View on PubMed)

Other Identifiers

5R01MH100455

Identifier Type: NIH

Identifier Source: secondary_id

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R01MH100455

Identifier Type: NIH

Identifier Source: org_study_id

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